Salvin Dental Specialties, LLC
Charlotte, NC, US
SALVIN DENTAL SPECIALTIES, LLC appears in FDA device records in Charlotte, NC. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Salvin Dental Specialties, LLC between 2008 and 2017. The busiest year on record is 2008, with 1. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2010 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K161857 | Salvin Tenting Screw System | DZL | Substantially Equivalent | |
| K160493 | Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm | NPK | Substantially Equivalent | |
| K100182 | SALVIN DENTAL SPECIALTIES FIXATION SCREW | DZL | Substantially Equivalent | |
| K073342 | SALVIN DENTAL SPECIALTIES, INC., FIXATION SCREW | DZL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1066741 | 3003005156 | SALVIN DENTAL SPECIALTIES, LLC | 3450 Latrobe Dr, CHARLOTTE, NC 28211 US | 2026 | and 65 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- EIFAccessories, Retractor, Dental
- GESBlade, Scalpel
- EJLBur, Dental
- KTZCaliper
- EMMChisel, Osteotome, Surgical
- EKECurette, Operative
- EMSCurette, Periodontic
- EMKCurette, Surgical, Dental
- KBLDepressor, Metal Tongue, Surgical
- KKXDrape, Surgical, Antimicrobial
- EMJElevator, Surgical, Dental
- GEGElevator, Surgical, General & Plastic Surgery
- EHZEvacuator, Oral Cavity
- EKCExcavator, Dental, Operative
- EMIFile, Bone, Surgical
- EMRFile, Periodontic
- HTDForceps
- EMHForceps, Rongeur, Surgical
- EMGForceps, Tooth Extractor, Surgical
- KBNGag, Mouth
- EILGauge, Depth, Instrument, Dental
- FYAGown, Surgical
- EJBHandle, Instrument, Dental
- GDZHandle, Scalpel
- EMDHemostat, Surgical
- FHQHolder, Needle, Gastroenterologic
- HXKHolder, Needle; Orthopedic
- DZPInstrument, Diamond, Dental
- DZNInstruments, Dental Hand
- EAYLight, Fiber Optic, Dental
- HXLMallet
- GFJMallet, Surgical, General & Plastic Surgery
- EMPMarker, Periodontic
- EAXMirror, Mouth
- DZMNeedle, Dental
- FMINeedle, Hypodermic, Single Lumen
- JEYPlate, Bone
- EJYPliers, Operative
- HTCPliers, Surgical
- EIXProbe, Periodontic
- EMEPunch, Biopsy, Surgical
- EISRemover, Crown
- EIGRetractor, All Types
- EIRScissors, Collar And Crown
- EGNScissors, Surgical Tissue, Dental
- DZLScrew, Fixation, Intraosseous
- HXXScrewdriver
- GAFSpatula, Surgical, General & Plastic Surgery
- GALSuture, Absorbable, Natural
- GAMSuture, Absorbable, Synthetic, Polyglycolic Acid
- GAPSuture, Nonabsorbable, Silk
- GARSuture, Nonabsorbable, Synthetic, Polyamide
- GATSuture, Nonabsorbable, Synthetic, Polyethylene
- GAWSuture, Nonabsorbable, Synthetic, Polypropylene
- EICSyringe, Periodontic, Endodontic, Irrigating
- EIDSyringe, Restorative And Impression Material
- FTYTape, Measuring, Rulers And Calipers
- FSMTray, Surgical, Instrument
- HWKTrephine
- KGNWound Dressing With Animal-Derived Material(S)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain